Guidelines for prescription drug marketing in India-OPPI

7/23/2019 Guidelines for prescription drug marketing in India-OPPI

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Regulatory guidelines for

promotion of

Prescription drugs in India.

Mark IV Medical communication


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The Organization ofPharmaceutical Producers of India(OPPI) has developed

a code of practice for its members,

based on the IFPMA.



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Sets out standards for ethical

promotion of pharmaceuticalproducts to healthcareprofessionals.

Implementation of the code is a matterof self regulation and self discipline



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Does NOT seek to regulate -

Promotion of prescription drugs to consumers(DTC advertising).

romo on o se me ca on pro uc smedications).

Provision ofnon promotional information.



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Industry relationships with healthcareprofessionals must support, and be consistentwith, the professional responsibilities thathealthcare professionals have towards their

patients.

Pharmaceutical companies must maintain high

ethical standards when conducting promotionalactivities and comply with applicable legal and

professional requirements



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All printed promotional materials other than

reminder advertisements must be legible andinclude :

the name of the product (normally the brand,

the active ingredients,

the name and address of the pharmaceuticalcompany or its marketing agent,

date of production of the advertisement,

the abbreviated prescribing information.



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This should include the following:

Approved Indications

Method of use

Succinct statement of contraindications,precautions and side effects



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Promotional material should not mislead by

distortion, exaggeration, undue emphasis oromission, or in any other way

Absolute or all-embracing claims should be used

with caution and only with adequatequalification and substantiation.

Descriptions such as safe and no side effects

should generally be avoided and should alwaysbe adequately qualified



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Promotion should be capable of

substantiation either by reference to theapproved labeling or by scientific evidence.Such evidence should be made available, on

, .



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It is a short advertisement consisting of

Name

Simple statement of indications todesignate therapeutic category

Such reminders may avoid API.



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Promotion should not bedisguised. Clinical assessments,post-marketing surveillance andexperience programmes, and post-

authorization studies must not bedisguised promotion.

products and their uses, whether ornot promotional in nature, that issponsored by a company should

clearly indicate by whom it hasbeen sponsored



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In accordance with local laws and regulations,free samples of a pharmaceutical product maybe supplied to healthcare professionals in orderto enhance patient care.

misused.

Companies should have adequate systems ofcontrol and accountability for samples provided

to healthcare professionals, including how tolook after such samples while they are in thepossession of medical representatives



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CashPayments in cash or cash equivalents (such as giftcertificate) must not be offered to healthcareprofessionals.

Personal gifts

Gifts for the personal benefit of healthcareprofessionals (including, but not limited to, music CDs,

DVDs, sporting or entertainment tickets, electronicitems) must not be provided or offered.

Cultural courtesy gifts

An inexpensive gift not related to the practice ofmedicine may be given on an infrequent basis tohealthcare professionals in acknowledgement ofsignificant national, cultural or religious holidays.



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Promotional aidsPromotional aids or reminder items may beprovided or offered to healthcareprofessionals and appropriate

administrative staff, provided that the giftis of minimal value and relevant to thepractice of the healthcare professional.

Medical Utilit items

Items of medical utility may be offered orprovided free of charge, provided that suchitems are of modest value and beneficial tothe provision of medical services and forpatient care.



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Including audiovisuals

The same requirements that apply toprinted materials also apply to electronic

.



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The identity of the pharmaceutical company andof the intended audience should be readily

apparent.

The content should be appropriate for the.

The presentation (content, links, etc.) should beappropriate and apparent to the intendedaudience.

India-specific information should comply withlocal laws and the Drugs and Magic remedies Act.



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Limited to,

Travel

Accommodation

Registration feesMark IV Medical communication


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Companies should avoid usingrenowned or extravagant venues.

Hospita ity s ou e imite tomoderate and reasonable refreshmentsand/or meals incidental to the mainpurpose of the event and should be

provided only to participants in theevent and not their guests.



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As a general rule, the hospitalityprovided should not exceed whathealthcare professional recipientswould normally be prepared to pay forthemselves.

No stand-alone entertainment or

other leisure or social activities shouldbe provided or paid for by membercompanies. At events, entertainmentof modest nature, which is

secondary to refreshmentsand/or meals, is allowed.



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Payments of reasonable fees and reimbursement

may be provided to healthcare professionalswho are providing genuine services as speakersor presenters on the basis of a written

.

Other Healthcare professionals cannot becompensated for time spent in attending an

event, e.g. a company-sponsored meeting orscientific congress.



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Promotional material (excluding

promotional aids) for a pharmaceuticalproduct not registered in the country ofthe event should be accompanied by

a suitable statement indicating thecountries in which the product isregistered,

an explanatory statement indicatingthat registration conditions differinternationally.



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Medical Animation Library

2D/3D Medical & Scientific Illustrations

2D/3D Medical & Scientific Animations

Flash based Interactive Applications

Websites & Health Portals for Pharmaceutical &Healthcare Industry

Written by-Dr. Neelesh BhandariMD (Path), PGP Human RightsAdvisor (Medical Communications)Mark IV Medical Communications.http://tinyurl.com/drneelesh



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Guidelines for prescription drug marketing in India-OPPI